Safety Manager - Cell and Gene

Emmes Group•Rockville, MD

23h•Remote

About The Position

The TA Safety Manager will implement Pharmacovigilance and Medical Monitoring (PMM) activities in collaboration with other members of the PMM group. The incumbent will supervise and manage activities of Safety Monitors and administrative support employees working in PMM (if relevant) and supervise the services of Pharmacovigilance contractors (if relevant) within the assigned TA to include utilization and training requirements and will also be responsible for safety monitoring for all interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor or Medical Officers and the project team. In addition, the TA Safety Manager supervises the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers or Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The TA Safety Manager supports the adherence to Good Pharmacovigilance Practice (GVP) and to other relevant Pharmacovigilance requirements across the organization.

Requirements

Bachelor's degree in pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice.
7-9 years in clinical practice, research, or pharmaceutical medicine (Clinical Research Organization (CRO), pharma company, etc.) with 3 years' experience in safety monitoring/pharmacovigilance.
1-3 years mentorship and/or managerial experience, including PV project management with working knowledge of MedDRA and WHO Drug coding
Understanding of clinical drug development.
Knowledge of clinical trial associated pharmacovigilance services; collecting, processing and reporting of safety signals.
Knowledge of Good Clinical Practice and Good Pharmacovigilance Practice.
Demonstrated use of medical terminology and ability to extract information to create a case history.
Working knowledge of MedDRA and WHO Drug coding strongly preferred.
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically and medically sound and understandable way.
Excellent oral and written communication skills.
Ability to work as a team member and function on a cross functional team.

Responsibilities

Directs and oversees a team of assigned Safety Monitors Europe to implement Safety Monitoring activities and reach objectives.
Contributes to the selection and drives onboarding, performance management and personal development plans of new employees.
Supervises maintenance and execution of mandatory training curriculums of direct reports.
Coordinates or personally performs safety monitoring activities in cooperation with project Medical Monitor.
Reviews safety events.
Oversees the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
Provides first line evaluation of serious adverse events (SAEs).
Communicates with site staff regarding reported AEs or SAEs to gather additional information.
Prepares a summary narrative for each reported SAE suitable for inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
Coordinates the timely completion and submission of required reports to health authorities and business partners.
Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
Reviews adverse events for the study on a regular basis.
Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
Responds to site, Client, pharmaceutical partner requests for information regarding safety in clinical trials (both interventional and non interventional).
Participates in DSMB or other safety review committee (SRC) meetings as necessary.
Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual report, and periodic safety reports.
Coordinates with project staff.
Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Monitoring Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
Contributes to the development and implementation of the safety Case Report Forms (CRF) and Safety Monitoring Plans (SaMP).
Ensures maintenance of documentation required by corporate and project SOPs.
Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
Coordinates close cooperation between PVOs and other Emmes roles, with special focus on cooperation with Medical Officers or Medical Monitors.
Pays special attention to situations when Emmes provides services parallel to PV also other services to the same Client (such as Scientific Services, Regulatory services, etc.)
Ensures that all documentation relevant for the assigned project is always audit/inspection ready.
Enforces that the delivery of services to the specific Client is regularly monitored and invoiced in a transparent way in full compliance with the relevant contract.
Represents Emmes in case of audit or inspection directly or indirectly related to the specific PV project.
Guarantees compliance and adherence to the quality standards.
Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned, the consistency with GVP, relevant local and international legislation and with requirements of relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA), etc.
Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
Directs other corporate activities including annual SOP reviews, development and teaching of Emmes classes, participation in corporate safety meetings/activities, and other corporate PV activities.
Coordinates close cooperation between Safety Monitors and other Emmes roles, with special focus on cooperation with Medical Officers or Medical Monitors.
Performs other duties as assigned.
Complies with all policies and standards.